Deployment Health in Regular Military Women (DHRMS)

July 18, 2019 updated by: Anne G SAdler, Iowa City Veterans Affairs Medical Center

Combat, Sexual Assault and Post-Traumatic Stress in OIF/OEF Military Women

The purpose of this study is to determine potential risk factors for physical and sexual assault in regular military women (as opposed to Reserve and National Guard). In addition, this study seeks to determine associations between service women's violence exposures and: current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and civilian healthcare.

Study Overview

Detailed Description

Background: The proposed study of Regular Military service women builds on and extends a funded VA HSR&D grant currently investigating similar objectives in Reserves and National Guard (R/NG) service women. This proposed study addresses the radically changing DoD and DVA health care delivery needs of two priority populations: women exposed to combat, and women sexually assaulted during military. There is a limited understanding of the complex relationship between these traumatic exposures and women's health outcomes, such as post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) and with their subsequent health service use or barriers to care.

Objectives: The objectives are: 1) To identify and describe organizational, situational, and individual risk factors for physical and sexual assault (i.e., victimization) in women who have served or are currently serving in the Regular Military in Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) by deployment status (those who are deployed to combat related regions once, those deployed more than once, those serving in non-combat related areas outside of the continental United States (US), or those serving within the continental US. 2) To determine associations between PTSD, TBI, and physical and sexual assault during OEF/OIF with current physical and mental health status and health risk behaviors by deployment status. 3) To identify current internal and external barriers to DoD, DVA, and civilian health services in relationship to women's deployment and victimization status and the association between PTSD and TBI; 4) To identify and describe differences between Regular Military and R/NG populations for each of these objectives.

Methods: We propose a cross sectional study design with two sequential phases. Phase 1 would include focus groups to refine the current study interview specific to Regular Military populations. Phase 2 would involve the identification and successful interviewing of 669 Regular Military service women, using random sampling with stratification by deployment status, state of service accession, and service branch. Building on our current study, women will be selected from five states: Iowa, Illinois, Kansas, Missouri, and Nebraska. Potential study participants will be mailed an information summary and asked to take part in a study assessing the deployment health of military women. 1058 women will be contacted to obtain the target of 669 completed interviews. Consenting participants (167 per deployment group) will complete a telephone interview that assesses socio-demographic variables, trauma exposures, health history, current health status, military environmental factors (organizational and situational factors), military and DVA health care and barriers to this care, and self reported service use. Descriptive analysis and multiple logistic regression analysis will be used.

Implications: It is unclear if the needs of military women are met by current combat-associated PTSD treatments originally based on male populations. It is anticipated that our findings will improve understanding of the health risks and outcomes of deployed Regular Military service women in contrast to women serving in the R/NG (with PTSD and TBI as key outcome variables). Our results consequently will have implications for DoD and DVA evidence based interventions for both primary prevention and care.

Study Type

Observational

Enrollment (Actual)

871

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Iowa City, Iowa, United States, 52246
        • Anne G. Sadler, Ph.D.; VAMC
      • Iowa City, Iowa, United States, 52246
        • Iowa City VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Women and Men who have or are currently serving in the USA regular military.

Description

Inclusion Criteria:

  • Focus Group:

    • Men or women who have or are currently active duty regular military (RM) of OIF/OEF service eras (10/7/01- present)
  • Interview phase:

    • Women, who have or are currently serving active duty RM during OIF/OEF service eras

Exclusion Criteria:

  • Focus Group:

    • Disabilities that render incapable of hearing
    • Comprehending
    • Communicating in a group or inhibit travel to focus group
  • Interview phase:

    • Disabilities that render incapable of hearing
    • Comprehending
    • Communicating independently with interviewers by telephone
    • Not having telephone and unable to access a nearby VA or other possible resource to contact toll free number.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
D0
Not deployed
D1
Deployed to combat-related regions once
D2
Deployed to combat related regions more than once
D3
Deployed outside of the continental US but not to combat related regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.
Time Frame: Months 28-42 of grant
Months 28-42 of grant

Secondary Outcome Measures

Outcome Measure
Time Frame
Traumatic brain injury
Time Frame: Months 28-42 of grant
Months 28-42 of grant
Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services
Time Frame: Months 28-42 of grant
Months 28-42 of grant
Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).
Time Frame: Months 28-42 of grant
Months 28-42 of grant
PTSD
Time Frame: Months 28-42 of Grant
Months 28-42 of Grant
Current medical health, including reproductive health
Time Frame: Months 28-42 of grant
Months 28-42 of grant
Deployment factors associated with risk of violence/health
Time Frame: Months 28-42 of grant
Months 28-42 of grant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne G Sadler, Ph.D., US Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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